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Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

NCT ID: NCT00471146

Last Updated: 2012-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

Detailed Description

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This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

Conditions

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Carcinoma, Pancreatic Ductal

Keywords

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Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

AG-013736

Intervention Type DRUG

oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.

Gemcitabine

Intervention Type DRUG

intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.

B

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.

placebo

Intervention Type DRUG

placebo

Interventions

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AG-013736

oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.

Intervention Type DRUG

Gemcitabine

intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.

Intervention Type DRUG

Gemcitabine

intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
* Adequate renal, hepatic and bone marrow function.
* Performance status 0 or 1.

Exclusion Criteria

* Prior treatment with any systemic chemotherapy for metastatic disease.
* Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
* Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
* Inability to take oral medication.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Antioch, California, United States

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Corona, California, United States

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Glendora, California, United States

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La Jolla, California, United States

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La Jolla, California, United States

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LaVerne, California, United States

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Pasadena, California, United States

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Pleasent Hill, California, United States

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Pomona, California, United States

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Pomona, California, United States

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Rancho Cucamonga, California, United States

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Rancho Mirage, California, United States

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Redlands, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Leandro, California, United States

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West Covina, California, United States

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Hollywood, Florida, United States

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Pembroke Pines, Florida, United States

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Stuart, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Augusta, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Alton, Illinois, United States

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Chicago, Illinois, United States

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Beech Grove, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Shelbyville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Annapolis, Maryland, United States

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Burlington, Massachusetts, United States

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Peabody, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Columbus, Mississippi, United States

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Corinth, Mississippi, United States

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Southaven, Mississippi, United States

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Tupelo, Mississippi, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Mineola, New York, United States

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Syracuse, New York, United States

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Canton, Ohio, United States

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Columbus, Ohio, United States

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Sylvania, Ohio, United States

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Portland, Oregon, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Round Rock, Texas, United States

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Salt Lake City, Utah, United States

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Lynchburg, Virginia, United States

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Everett, Washington, United States

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Federal Way, Washington, United States

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Kennewick, Washington, United States

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Lakewood, Washington, United States

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Puyallup, Washington, United States

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Tacoma, Washington, United States

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Bahía Blanca, Buenos Aires, Argentina

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La Plata, Buenos Aires, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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St Leonards, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Clayton, Victoria, Australia

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East Bentleigh, Victoria, Australia

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Wels, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Wilrijk, , Belgium

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Edmonton, Alberta, Canada

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Kelowna, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Kingston, Ontario, Canada

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Kingston, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Clichy, , France

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La Chaussée-Saint-Victor, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Paris, , France

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Pessac, , France

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Rouen, , France

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Saint-Herblain, , France

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Berlin, , Germany

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Dresden, , Germany

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Essen, , Germany

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Greifswald, , Germany

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Magdeburg, , Germany

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Mannheim, , Germany

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München, , Germany

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Oldenburg, , Germany

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Ulm, , Germany

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Shatin, NT, Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Kaposvár, , Hungary

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Szentes, , Hungary

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Zalaegerszeg, , Hungary

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Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Kochi, Kerala, India

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Andhra, Pradesh, India

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Chennai, Tamil Nadu, India

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Dublin, , Ireland

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Dublin, , Ireland

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Bologna, , Italy

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Catania, , Italy

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Milan, , Italy

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Milan, , Italy

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Padua, , Italy

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Verona, , Italy

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Nagoya, Aichi-ken, Japan

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Chiba, Chiba, Japan

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Kashiwa-shi, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Yokohama, Kanagawa, Japan

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Osaka, Osaka, Japan

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Suntougun, Shizuoka, Japan

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Chuo-ku, Tokyo, Japan

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Amsterdam, North Holland, Netherlands

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Amsterdam, , Netherlands

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Moscow, Moscow, Russia

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Moscow, , Russia

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Moscow, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Sochi, , Russia

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Singapore, Singapore, Singapore

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Singapore, , Singapore

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Cape Town, , South Africa

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Observatory, , South Africa

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Parktown, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Sandton, , South Africa

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Palma de Mallorca, Balearic Islands, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

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Madrid, Madrid, Spain

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Móstoles, Madrid, Spain

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Málaga, Malaga, Spain

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Pamplona, Navarre, Spain

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Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

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Toledo, Toledo, Spain

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Lund, , Sweden

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Uppsala, , Sweden

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Winterthur, , Switzerland

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Kuei-Shan Jsoamg, Taoyuan County, Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Whitchurch, Cardiff, United Kingdom

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Maidstone, Kent, United Kingdom

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Leicester, Leicestershire, United Kingdom

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Withington, Manchester, United Kingdom

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Northwood, Middlesex, United Kingdom

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Birmingham, , United Kingdom

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Birmingham, , United Kingdom

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Edinburgh, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Southhampton, , United Kingdom

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Countries

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Portugal United States Argentina Australia Austria Belgium Canada France Germany Hong Kong Hungary India Ireland Italy Japan Netherlands Russia Singapore South Africa South Korea Spain Sweden Switzerland Taiwan United Kingdom

References

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Kindler HL, Ioka T, Richel DJ, Bennouna J, Letourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.

Reference Type DERIVED
PMID: 21306953 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061028&StudyName=Study%20Of%20Gemcitabine%20Plus%20AG-013736%20Versus%20Gemcitabine%20For%20Advanced%20Pancreatic%20Cancer.

To obtain contact information for a study center near you, click here.

Other Identifiers

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A4061028

Identifier Type: -

Identifier Source: org_study_id